Effect of Vitamin D Supplementation on Erythropoietin Dosage in Hemodialysis Patients Who Have Vitamin D Deficiency

NCT ID: NCT00915317

Last Updated: 2015-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-03-31

Brief Summary

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While vitamin D supplementation is safe and effective in repleting vitamin D levels in dialysis patients, the impact on anemia is unknown. The majority of hemodialysis patients require erythropoietin supplementation to maintain their serum hemoglobin between 11 and 12 gm/dL, a drug that is both costly and associated with significant side effects. If repletion of vitamin D significantly decreases erythropoietin requirements in hemodialysis patients, it would result in a substantial reduction in patient care costs. Our aim is to study the impact of ergocalciferol supplementation in hemodialysis patients with 25-hydroxyvitamin D deficiency. The investigators anticipate approximately 30% reduction in erythropoietin dose requirement in our hemodialysis population.

Detailed Description

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Conditions

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Vitamin D Deficiency Anemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* All hemodialysis patients at the Kaiser Permanente Los Angeles Medical Center with vitamin D deficiency \[defined by 25-hydroxyvitamin D level less than 30 ng/ml\]

Exclusion Criteria

* Non-renal causes of anemia (myelodysplastic syndrome, multiple myeloma, pure red cell aplasia, thallassemia, and sickle cell anemia)
* Active cancer
* AIDS
* refused erythropoeitin, intravenous iron or vitamin D analogs in the past
* no erythropoeitin requirement for greater than 6 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Phillip S Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

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Kaiser Permanente Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Al-Aly Z, Qazi RA, Gonzalez EA, Zeringue A, Martin KJ. Changes in serum 25-hydroxyvitamin D and plasma intact PTH levels following treatment with ergocalciferol in patients with CKD. Am J Kidney Dis. 2007 Jul;50(1):59-68. doi: 10.1053/j.ajkd.2007.04.010.

Reference Type BACKGROUND
PMID: 17591525 (View on PubMed)

Coen G, Mantella D, Manni M, Balducci A, Nofroni I, Sardella D, Ballanti P, Bonucci E. 25-hydroxyvitamin D levels and bone histomorphometry in hemodialysis renal osteodystrophy. Kidney Int. 2005 Oct;68(4):1840-8. doi: 10.1111/j.1523-1755.2005.00603.x.

Reference Type BACKGROUND
PMID: 16164662 (View on PubMed)

Del Valle E, Negri AL, Aguirre C, Fradinger E, Zanchetta JR. Prevalence of 25(OH) vitamin D insufficiency and deficiency in chronic kidney disease stage 5 patients on hemodialysis. Hemodial Int. 2007 Jul;11(3):315-21. doi: 10.1111/j.1542-4758.2007.00186.x.

Reference Type BACKGROUND
PMID: 17576296 (View on PubMed)

DeVille J, Thorp ML, Tobin L, Gray E, Johnson ES, Smith DH. Effect of ergocalciferol supplementation on serum parathyroid hormone and serum 25-hydroxyvitamin D in chronic kidney disease. Nephrology (Carlton). 2006 Dec;11(6):555-9. doi: 10.1111/j.1440-1797.2006.00698.x.

Reference Type BACKGROUND
PMID: 17199797 (View on PubMed)

Ghazali A, Fardellone P, Pruna A, Atik A, Achard JM, Oprisiu R, Brazier M, Remond A, Moriniere P, Garabedian M, Eastwood J, Fournier A. Is low plasma 25-(OH)vitamin D a major risk factor for hyperparathyroidism and Looser's zones independent of calcitriol? Kidney Int. 1999 Jun;55(6):2169-77. doi: 10.1046/j.1523-1755.1999.00480.x.

Reference Type BACKGROUND
PMID: 10354266 (View on PubMed)

Gonzalez EA, Sachdeva A, Oliver DA, Martin KJ. Vitamin D insufficiency and deficiency in chronic kidney disease. A single center observational study. Am J Nephrol. 2004 Sep-Oct;24(5):503-10. doi: 10.1159/000081023. Epub 2004 Sep 22.

Reference Type BACKGROUND
PMID: 15452403 (View on PubMed)

LaClair RE, Hellman RN, Karp SL, Kraus M, Ofner S, Li Q, Graves KL, Moe SM. Prevalence of calcidiol deficiency in CKD: a cross-sectional study across latitudes in the United States. Am J Kidney Dis. 2005 Jun;45(6):1026-33. doi: 10.1053/j.ajkd.2005.02.029.

Reference Type BACKGROUND
PMID: 15957131 (View on PubMed)

Martins D, Wolf M, Pan D, Zadshir A, Tareen N, Thadhani R, Felsenfeld A, Levine B, Mehrotra R, Norris K. Prevalence of cardiovascular risk factors and the serum levels of 25-hydroxyvitamin D in the United States: data from the Third National Health and Nutrition Examination Survey. Arch Intern Med. 2007 Jun 11;167(11):1159-65. doi: 10.1001/archinte.167.11.1159.

Reference Type BACKGROUND
PMID: 17563024 (View on PubMed)

Saab G, Young DO, Gincherman Y, Giles K, Norwood K, Coyne DW. Prevalence of vitamin D deficiency and the safety and effectiveness of monthly ergocalciferol in hemodialysis patients. Nephron Clin Pract. 2007;105(3):c132-8. doi: 10.1159/000098645. Epub 2007 Jan 16.

Reference Type BACKGROUND
PMID: 17228173 (View on PubMed)

Shah N, Bernardini J, Piraino B. Prevalence and correction of 25(OH) vitamin D deficiency in peritoneal dialysis patients. Perit Dial Int. 2005 Jul-Aug;25(4):362-6.

Reference Type BACKGROUND
PMID: 16022093 (View on PubMed)

Taskapan H, Ersoy FF, Passadakis PS, Tam P, Memmos DE, Katopodis KP, Ozener C, Akcicek F, Camsari T, Ates K, Ataman R, Vlachojannis JG, Dombros NA, Utas C, Akpolat T, Bozfakioglu S, Wu G, Karayaylali I, Arinsoy T, Stathakis CP, Yavuz M, Tsakiris DJ, Dimitriades AD, Yilmaz ME, Gultekin M, Oreopoulos DG. Severe vitamin D deficiency in chronic renal failure patients on peritoneal dialysis. Clin Nephrol. 2006 Oct;66(4):247-55. doi: 10.5414/cnp66247.

Reference Type BACKGROUND
PMID: 17063991 (View on PubMed)

Wolf M, Shah A, Gutierrez O, Ankers E, Monroy M, Tamez H, Steele D, Chang Y, Camargo CA Jr, Tonelli M, Thadhani R. Vitamin D levels and early mortality among incident hemodialysis patients. Kidney Int. 2007 Oct;72(8):1004-13. doi: 10.1038/sj.ki.5002451. Epub 2007 Aug 8.

Reference Type BACKGROUND
PMID: 17687259 (View on PubMed)

Zadshir A, Tareen N, Pan D, Norris K, Martins D. The prevalence of hypovitaminosis D among US adults: data from the NHANES III. Ethn Dis. 2005 Autumn;15(4 Suppl 5):S5-97-101.

Reference Type BACKGROUND
PMID: 16315387 (View on PubMed)

Zisman AL, Hristova M, Ho LT, Sprague SM. Impact of ergocalciferol treatment of vitamin D deficiency on serum parathyroid hormone concentrations in chronic kidney disease. Am J Nephrol. 2007;27(1):36-43. doi: 10.1159/000098561. Epub 2007 Jan 11.

Reference Type BACKGROUND
PMID: 17215573 (View on PubMed)

Other Identifiers

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5125

Identifier Type: -

Identifier Source: org_study_id

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